Welcome to our dedicated page for AstraZeneca news (Ticker: AZN), a resource for investors and traders seeking the latest updates and insights on AstraZeneca stock.
AstraZeneca PLC develops and commercializes prescription medicines across oncology, rare diseases, and BioPharmaceuticals, including cardiovascular, renal and metabolism, respiratory, and immunology. News about AZN commonly covers clinical-trial results, FDA and advisory-committee actions, product approvals, and updates to marketed medicines such as TRUQAP, BREZTRI, SAPHNELO, IMFINZI, IMJUDO, and ULTOMIRIS.
Company updates also address quarterly revenue and earnings trends, alliance and collaboration revenue, licensing transactions for pipeline assets, and governance changes. Recurring development themes include targeted oncology, COPD, asthma, systemic lupus erythematosus, liver cancer, prostate cancer, and rare or immune-mediated diseases.
AstraZeneca (AZN) and Daiichi Sankyo announced that Enhertu received a positive CHMP opinion in the EU as monotherapy for adults with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors lacking satisfactory options.
The recommendation, based on phase 2 DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02, showed confirmed ORRs of 51.4%, 52.9% and 46.9% respectively, with median DOR up to 14.2 months. The European Commission will now review the opinion.
AstraZeneca (AZN) will present new cancer and rare disease data at ASCO 2026 from more than 85 abstracts covering 10 approved and 13 pipeline medicines.
Key Phase III updates include EMERALD-3 in liver cancer, SERENA-6, DESTINY-Breast09, TROPION-Breast02 in metastatic breast cancer, POTOMAC in bladder cancer, and CARES for kappa light chain amyloidosis, plus early results for NT-175, AZD3470 and B7-H4 ADC Puxi-Sam.
AstraZeneca (NYSE:AZN) received US FDA approval for BAXFENDY (baxdrostat), the first aldosterone synthase inhibitor for adults with hypertension inadequately controlled on other drugs.
Approval is based on Phase III BaxHTN data showing placebo-adjusted seated systolic blood pressure reductions up to 9.8 mmHg at 12 weeks, with defined safety monitoring needs.
AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo received US FDA approval for ENHERTU in two new HER2-positive early breast cancer settings. ENHERTU is now authorized as neoadjuvant therapy for Stage II/III disease and as adjuvant therapy for patients with residual invasive disease after neoadjuvant treatment.
DESTINY-Breast11 showed a 67.3% pathologic complete response with ENHERTU followed by THP versus 56.3% with ddAC-THP. DESTINY-Breast05 showed a 53% reduction in invasive disease-free survival risk versus T-DM1 (HR 0.47) and 3-year IDFS of 92.4% versus 83.7%. ENHERTU carries a boxed warning for ILD/pneumonitis and embryo-fetal toxicity. A $155 million milestone payment from AstraZeneca to Daiichi Sankyo is triggered by these approvals, and ENHERTU is now a Category 1 NCCN-recommended adjuvant option for high-risk HER2-positive early breast cancer.
AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo received U.S. FDA approval for Enhertu in two new HER2 positive early breast cancer indications: neoadjuvant (stage 2/3, followed by THP) and adjuvant (residual invasive disease after neoadjuvant trastuzumab±pertuzumab and taxane).
DESTINY-Breast11 showed higher pCR (67.3% vs 56.3%), while DESTINY-Breast05 showed 53% lower invasive disease recurrence or death risk versus T-DM1 and three-year IDFS of 92.4% vs 83.7%. Enhertu now has nine approved indications. AstraZeneca will pay Daiichi Sankyo $155 million in milestones.
AstraZeneca (NASDAQ:AZN) reported high-level Phase III VOLGA results in muscle-invasive bladder cancer. Perioperative IMFINZI (durvalumab) plus neoadjuvant enfortumab vedotin showed statistically significant, clinically meaningful improvements in event-free survival and overall survival versus surgery-based standard of care in cisplatin-ineligible or cisplatin-declining patients.
A regimen adding IMJUDO (tremelimumab) also improved event-free survival with a favorable, but not yet statistically significant, overall-survival trend. Safety for IMFINZI with or without IMJUDO and EV was consistent with known profiles, and data will be shared with regulators and at future medical meetings.
AstraZeneca (NYSE:AZN) announced that an FDA Oncologic Drugs Advisory Committee (ODAC) voted 7-1 with 1 abstention that TRUQAP (capivasertib) plus abiraterone and ADT has a favorable benefit-risk profile for PTEN-deficient metastatic hormone-sensitive prostate cancer based on CAPItello-281.
CAPItello-281 showed a 19% reduction in risk of radiographic progression or death (HR 0.81; 95% CI 0.66-0.98; P=0.034), with median rPFS 33.2 vs 25.7 months (improvement 7.5 months). Grade ≥3 adverse events occurred in 67% vs 40.4% (comparator); OS data remain immature.
Pinetree Therapeutics announced AstraZeneca (LSE/STO/NYSE: AZN) has exercised its option to obtain an exclusive global license to develop and commercialize PTX-299, a bispecific antibody degrader targeting EGFR.
The option exercise triggers a $25 million option-closing payment to Pinetree and makes AstraZeneca responsible for global development and commercialization; the deal includes future development, regulatory, and commercial milestones plus tiered royalties, with total potential value exceeding $500 million.
AstraZeneca (NYSE:AZN) reported Q1 2026 Total Revenue of $15,288m (CER +8%) and Product Revenue of $15,211m. Core EPS was $2.58 and reported EPS $1.99. Growth was driven by double‑digit Oncology and Rare Disease performance and multiple Phase III positive readouts and approvals.
Guidance for FY 2026 at CER was reconfirmed: mid‑to‑high single‑digit Total Revenue growth and low double‑digit Core EPS growth; Core tax rate 18–22%.
AstraZeneca (NYSE: AZN) announced FDA approval of BREZTRI Aerosphere for maintenance treatment of asthma in patients 12 years and older, marking the first single-inhaler fixed-dose triple therapy approved for this population.
Approval was based on Phase III KALOS and LOGOS (≈4,300 patients) showing significant FEV1 improvement versus ICS/LABA and a rapid onset of action within five minutes; no new safety signals identified. BREZTRI was prescribed to >6.8 million patients globally in 2025.